TBN (Jeffrey Clark, MDMGH, Acting) Deputy Associate Director of Administration for Clinical Research Operations (80% effort, 50% salary requested from the CCSG) This new senior level position, reporting to the DF/HCC Associate Director for Administration, will manage and coordinate administrative functions that support the integrated DF/HCC clinical trials system for increased efficiency and effectiveness as well as improved integration of trials at all participating sites. This position will also carry the title of DFCI VP for Clinical Research Operations (and reports in that capacity to the DFCI SVP for Research, Dr. Faye Austin, who also serves as DF/HCC Associate Director for Administration.). Areas of responsibility for this position are: [unreadable] Administrative systems improvements for review, activation and conduct of trials; [unreadable] Education of investigators and study staff in the requirements for conduct of clinical research; [unreadable] Improved resource management; and increased accountability; [unreadable] Coordination and improvement of business contracting with industry (no CCSG support requested for this role). Specifically, the Director will oversee the development of streamlined process to assure the quality and timeliness of: [unreadable] Development of protocols from the endorsement of new concepts by disease programs to the approval of protocols by the SRC and IRB; [unreadable] Development and implementation of required investigator training in the conduct of clinical research, e.g. Good Clinical Practice for Clinical Investigation; [unreadable] Proper performance of approved protocols in regards to safety, accuracy, and completeness of data collection; [unreadable] Development and implementation of information systems to support clinical trials; and, [unreadable] Coordination of these efforts with biostatistics and research pharmacy support. In this role, s/he will work collaboratively with the Director, OPRS to assess OPRS process management needs and provide needed resources to that adequate systems and resources are in place for efficient SRC and IRB review of protocols. Responsibilities include the'management and oversight of the CTEO, QACT, and Clinical Research Management, including, data management for all Cancer Center trials. This role has been accomplished by a reorganization^ existing offices/positions to achieve improved efficiencies and oversight by having clearer lines of responsibility, reporting, and accountability. The search for this position is ongoing, with a formal search committee in place, assisted by a search firm. Candidates are being screened by the search firm in December-January and interviews will commence after February 1, 2005. Support is request for 50% effort from the CCSG; the remaining 30% effort committed to the CCSG will be supported b institutional funds. The remaining 20% effort is dedicated to business development with industry, and this effort will be supported by institutional funds. Jeffrey W. Clark, MDMGH (20% effort requested), Dr. Clark serves as the Medical Director of the Clinical Research Operations Core (CROC) and, in this role, is responsible for all medical aspects of the integrated clinical trials infrastructure of the Cancer Center. In this role, he assists the Director in the medical aspects of managing the complex DF/HCC integrated clinical trials systems, including overseeing the processes involved in development of appropriate information systems for conduct of trials from the physicians' perspective; and providing assistance to clinical investigators in the implementation of Good Clinical Practice for clinical investigation. Dr. Clark has dual reporting channels in the Cancer Center. For all administrative matters he reports to Faye Austin, PhDDFCI, Associate Director for Clinical Sciences. As Medical Director of CROC, Dr. Clark spends 20% of his time on the clinical trials process for the DF/HCC; this is the level of support currently provided for his role in the CCSG. Jane RussellDFCI, Quality Assurance Officer (25% effort requested), In this capacity Ms. Russell has responsibility for overseeing systems related to clinical trials for DF/HCC. She manages the internal protocol audit system, the QACT, including the protocol registration system, the accrual monitoring process with CLINPOC, computerization and quality control of DF/HCC-initiated clinical trials data. She has a major role in assuring that regulatory requirements are met during the implementation of clinical trials, and works with the network coordinator in developing a strong infrastructure for affiliate participation in clinical trials. She has collaborated with NCI to centralize the process for certifying investigators (1572 approval) in the Cancer Center. Under Ms. Russell's leadership QACT received an award in 2002 for "Best Practice" in Human Research Protection from the Health Improvement Institute. In 2004 she worked with the Director of OPRS to obtain accreditation for our Human Research Protection Program from AAHRPP. Ms. Russell has a Bachelors Degree and 27 years experience in the cancer clinical trials arena at all levels. She has worked at the cooperative group institutional level as a data manager and data coordinator (ECOG), at the main institution for the group chairman for CALGB as coordinator of the program, as an affiliate coordinator for a Comprehensive Cancer Center, as the Director of QACT for Dana-Farber Cancer Institute, and most recently as the Quality Assurance Officer for Clinical Trials for DF/HCC. She was on the Consensus Panel for Platelet Transfusions at NIH as a lay representative, and has been a member of the site visit team twice for the State of Nebraska HHS, Cancer and Smoking Disease Research Program. Ms. Russell has also served as a member of audit teams for ECOG and CALGB.